Senior Director, Global Quality & Compliance, Biotech

Tr1X; San Diego (CA); On-site; USD 240,000 - 270,000; Full time

Benefits offered by this job

Discretionary bonus

Stock options

401(k) matching

Health insurance

PTO & holidays

Job summary

Tr1X is a clinical-stage biotechnology company developing engineered Tr1 cell therapies to restore immune balance. The Senior Director, Quality (SD) oversees the quality organization, shaping strategy, implementing systems, and driving continuous improvement to ensure product integrity and patient safety.

This role partners with internal and external stakeholders to meet regulatory requirements and business goals.

Qualifications

• B.S. degree in a scientific discipline with pharmaceutical/biologics relevance.
• Minimum 12 years in FDA-regulated manufacturing quality ops.
• 5+ years leadership in quality with supervisory experience.

Responsibilities

• Provide oversight of quality risks and report to senior stakeholders.
• Manage global audit program for vendor/supplier compliance and metrics.
• Maintain quality management system and governance for GxP data.
• Ensure compliance with FDA/EMA/ICH guidelines.
• Lead and mentor quality teams across QA, QC, document control, and CQA.
• Collaborate with clinical ops, CROs, and manufacturing to ensure GxP compliance.

Skills

Quality leadership

GxP compliance

Regulatory inspections

Biologics manufacturing

Quality management systems

Budget forecasting

Communication

Project planning

Cross-functional collaboration

Education

B.S. in science

Job description

Tr1X is a clinical-stage biotechnology company developing engineered Tr1 cell therapies to restore immune balance. The Senior Director, Quality (SD) oversees the quality organization, shaping strategy, implementing systems, and driving continuous improvement to ensure product integrity and patient safety.

This role partners with internal and external stakeholders to meet regulatory requirements and business goals.